See also:

VISP (Toole) study, 2004	TRC8857
	download pdf: high dose - folic acid, vit B12 and vit B6 | plasma homocysteine lowering intervention for cardiovascular prevention

Treatments

Studied treatment	high-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12) 25 mg of pyridoxine, 0.4 mg of cobalamin, and 2.5 mg of folic acid
Control treatment	low-dose of folic acid, pyridoxine (vitamin B6), and cobalamin (vitamin B12) 200 ìg of pyridoxine, 6 ìg of cobalamin, and 20 ìg of folic acid

Patients

Patients	adults with nondisabling cerebral infarction
Inclusion criteria	Nondisabling ischemic stroke(Modified Rankin Stroke Scale =25th percentile for North American stroke population; age >=35 years
Baseline characteristics	Age (yr) 66 y  Male sex 63%  BMI 28.1  diabetes (%) 29%

Method and design

Randomized effectives	1827 / 1853 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	2 y
Lost to follow-up	0.84% (31/)
Number of centre	56
Geographic area	United States, Canada, Scotland
Hypothesis	Superiority
Primary endpoint	Recurrent cerebral infarction

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
	Studied treat.	Control treat.
Any Ischemic stroke	152 / 1827 (8,3%)	148 / 1853 (8,0%)	1,04	[0,84;1,29]
Fatal or disabling Ischemic stroke	21 / 1827 (1,1%)	18 / 1853 (1,0%)	1,18	[0,63;2,21]
Any CHD	114 / 1827 (6,2%)	123 / 1853 (6,6%)	0,94	[0,73;1,20]
MI or fatal CHD	72 / 1827 (3,9%)	81 / 1853 (4,4%)	0,90	[0,66;1,23]
Any Ischemic stroke or CHD	249 / 1827 (13,6%)	257 / 1853 (13,9%)	0,98	[0,84;1,16]
Fatal or disabling stroke or MI or fatal CHD	89 / 1827 (4,9%)	98 / 1853 (5,3%)	0,92	[0,70;1,22]
Death	99 / 1827 (5,4%)	117 / 1853 (6,3%)	0,86	[0,66;1,11]
Ischemic stroke, CHD, death	303 / 1827 (16,6%)	316 / 1853 (17,1%)	0,97	[0,84;1,12]
Fatal or disabling stroke, MI, death	156 / 1827 (8,5%)	170 / 1853 (9,2%)	0,93	[0,76;1,15]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

All cause death

99 / 1827
117 / 1853
0,86 [0,66;1,11]

stroke (fatal and non fatal)

152 / 1827
148 / 1853
1,04 [0,84;1,29]

Non fatal MI

72 / 1827
81 / 1853
0,90 [0,66;1,23]

cardiovascular events

303 / 1827
316 / 1853
0,97 [0,84;1,12] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
All cause death	99 / 1827 (5,4%)	117 / 1853 (6,3%)	0,86	[0,66;1,11]	Death	0
Non fatal MI	72 / 1827 (3,9%)	81 / 1853 (4,4%)	0,90	[0,66;1,23]	MI or fatal CHD	0
cardiovascular events	303 / 1827 (16,6%)	316 / 1853 (17,1%)	0,97	[0,84;1,12]	Ischemic stroke, CHD, death	0
stroke (fatal and non fatal)	152 / 1827 (8,3%)	148 / 1853 (8,0%)	1,04	[0,84;1,29]	Any Ischemic stroke	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 2 y)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
All cause death	5,42%	6,31%	-0,90%
Non fatal MI	3,94%	4,37%	-0,43%
cardiovascular events	16,58%	17,05%	-0,47%
stroke (fatal and non fatal)	8,32%	7,99%	0,33%

Meta-analysis of all similar trials:

plasma homocysteine lowering intervention in cardiovascular prevention for all type of patients

prevention in post stroke for patients with prior stroke or TIA

Reference(s)

TrialResults-center ID	TRC8857
Trials register #	NA

• Spence JD, Bang H, Chambless LE, Stampfer MJ. Vitamin Intervention For Stroke Prevention trial: an efficacy analysis.. Stroke 2005 Nov;36:2404-9
  Pubmed | Hubmed | Fulltext
• Toole JF, Malinow MR, Chambless LE, Spence JD, Pettigrew LC, Howard VJ, Sides EG, Wang CH, Stampfer M. Lowering homocysteine in patients with ischemic stroke to prevent recurrent stroke, myocardial infarction, and death: the Vitamin Intervention for Stroke Prevention (VISP) randomized controlled trial.. JAMA 2004 Feb 4;291:565-75
  Pubmed | Hubmed | Fulltext

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